FDA Issues Draft Guidance on Exemption Requests for Drug Supply Chain Law Requirements
The Food and Drug Administration on May 8 issued a draft guidance document detailing the process for obtaining exemptions from Drug Supply Chain Security Act (DSCSA) requirements. Under DSCSA, “trading partners,” including manufacturers, repackagers and wholesale distributors, can request waivers…
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if DSCSA requirements cause undue economic hardship or a waiver is appropriate for emergency medical reasons, or exemptions in order to maintain public health. Manufacturers and repackagers can also request exemptions if the product is packaged in a container too small to bear information required by DSCSA. Comments are due July 9.